Identification system

ABSTRACT

In an identification assembly of the type having an elongated flexible band with fastening means for locking to the limb of a patient wherein the improvement comprises the addition thereto of an identification label dispenser holding a plurality of patient identification labels, with the dispenser including means for holding the labels so that no label can be added without resultant indication thereof. All but one of the labels are removably held and removal thereof requires a pulling force which results in tearing of the label (in the vicinity of the holding means), with the securing of the pulling force insuring that no tampering has occurred. A method of correlating the identity between the patient and specimens taken therefrom sets forth the dispenser-attaching, specimen-drawing, label-removing and labelattaching steps required in carrying out this method.

Smith [111 3,818,897 [45] June 25, 1974 IDENTIFICATION SYSTEM [75]Inventor: Ward C. Smith, Corning, NY.

[73] Assignee: Corning Glass Works, Corning,

[22] Filed: Feb. 20, 1973 [21] Appl. No.: 334,013

Related US. Application Data [62] Division of Ser. No. 209,875, Dec. 20,1971, Pat. No.

[52] US. Cl. 128/2 F, 40/21 R [51] Int. Cl. G09f 3/14 [58] Field ofSearch 128/2 R, 1 R, 2 F, DIG. 5; 40/21 R, 21 C, 1.5, 2 R; 2/DIG. 7;206/D1G.

[56] References Cited UNITED STATES PATENTS 3,059,359 10/1962 Goldammer40/21 C 3,660,916 5/1972 McDermott et al. 40/21 C PrimaryExaminer-Richard A. Gaudet Assistant Examiner-Henry J. Recla Attorney,Agent, or Firm-Clarence R. Patty, Jr.; Burton R. Turner [57] ABSTRACT Inan identification assembly of the type having an elongated flexible bandwith fastening means for locking to the limb of a patient wherein theimprovement comprises the addition thereto of an identification labeldispenser holding a plurality of patient identification labels, with thedispenser including means for holding the labels so that no label can beadded without resultant indication thereof. All but one of the labelsare removably held and removal thereof requires a pulling force whichresults in tearing of the label (in the vicinity of the holding means),with theisecuring of the pulling force insuring that no tampering hasoccurred. A method of correlating the identity between the patient andspecimens taken therefrom sets forth the dispenser-attaching,specimen-drawing, labelremoving and label-attaching steps required incarrying out this method. 1

1 Claim, 4 Drawing Fignres 1 IDENTIFICATION SYSTEM BACKGROUND OF THEINVENTION This invention pertains to an identification system, morespecifically an identification assembly as well as a method for usingsame, particularly for hospital patients. This identification assemblyincludes a tamperproof identification label dispenser and identificationlabels for use in patient specimen identification, wherein the dispenseris incorporated into the flexible band that is irreversibly locked tothe limb of a patient.

In todays hospital routine, great emphasis is placed on the analyses ofpatients body fluids. In some cases, a single value may be diagnosticfor a given ailment, but in most cases it is an observable change invalues which is significant. A single abnomial value is usually re-run.In addition to diagnosis, this testing is also used to evaluate theeffect of a drug or specific treatment on the patient. Thus, testing maybe of the profile type for general health checks where many tests aredone once. It may be exploratory to find or confirm a specific ailment,or it may be done to evaluate treatment. The latter two testingobjectives usually require repetitive testing involving periodicextraction of body fluids (from every few minutes in such tests asglucose up-take to every few days in some cases of treatmentevaluation).

The hospital laboratory has several functional boundaries which create aneed for the use of several containers of a given body fluid, ratherthan a single container. Often each container of sample differs inadditives, or in the manner in which the sample is collected. In thecase of blood, three tubes may be collected. One container, having noadditives, will be used for blood chemistries. A second, similarcontainer, will be collected for seriological studies (a seconddepartment), while a third container with anticoagulant added, will beused for Hematology (a third dept. doing red and white cell counts, cellmorphology, clotting time, etc.). A further tube could also be collectedfor bacterial culture, still another department. In the case of urine,physical and microscopic studies, some chemistries are done in theurinalysis dept. If a culture is to be done, a separate sterilecontainer may be required along with a precise procedure for collectingThroat swabs and other body fluids requiring culture are placed from thecollection container into a broth which is incubated for several hours.The broth is then streaked onto one or several types of media and againincubated to obtain characteristics.

In addition to collection in conventional tubes and bottles, somesamples are smeared on to microscope slides. Others are collected inmicropipets less than one tenth of an inch in cross-section. Blood froma finger puncture may be aspirated into blood pipettes, then diluted andshaken before taken to the lab.

In summary, one to several body fluids may be collected in one toseveral containers having a diverse range of shapes andsizes. They aregenerally placed in a tray or rack with similar samples from many otherpatients during collection. When taken to the laboratory they are storedand disseminated to several different laboratory departments foranalysisDifferent analyses require a variety of different additives andcollecting procedures for a given patient fluid.

LII

The technician who collects patient samples is given a list or stack offorms with patient name, ward, bed or room number and type and quantityof sample. Blood is generally routinely collected first thing in themorning. The list usually contains 20 to 30 names and often there ismore than one technician collecting at the same time. The collectingtechnicians are usually female and with relatively little schooling,training or experience in the laboratory. (This is due to the relativelyhigh tum-over and the fact that the duties are more manual skilloriented than demanding of technical knowledge. As a result of thisgeneral job orientation one can expect a commensurate level ofperformance in sample handling and identification.)

Generally there are several procedures in use for pa tientidentification. lf a copy of the analysis check sheet for eachdepartment is sent with the technician, it may be wrapped around thesample and held with a rubber band. This may or may not be coupled withthe use of a grease pencil or label tape. (Neither check sheet, norgrease pencil is effective for Microcapillaries.) Of more generalpurpose is the use of pressure sensitive tape, with the technicianpre-labeling the tubes or the surface of her cart with strips torn froma tape roll. She has the option of pre-writing the identification orwriting it as she collects the samples.

Grease pencil rubs off in handling and multiple samples can getseparated from check sheets. Pressure sensitive tape is a good choicefor performance, but it does have problems, however. Frequently, a watersoluble ink is used which gets wet and smears and since the writer ofthe label is not the end user, legibility of hand writing is a commonproblem. In addition, it does take time to tear strips of tape, transferthem to a cart, write the identification, and then transfer them to thesample. Clerical error can result in transposing from list to container.

One company does print form label sheets which accompany their bloodsample tubes. However, they receive limited use as they require wettingto stick, which makes them awkward to use on the wards. A second companyhas begun adding pressure sensitive, form label sheets to their bloodcollection packs.

One problem that can arise in sample identification is collection fromthe wrong patient. For example, if the patient gets a room or bed shiftwithout a change in lab records and if the technician does not check thepatients wrist band, she may take the wrong patients sample. Generallyshe will label the samples from her list, thus relating more to bed orroom number rather than the patient, since this is easier to do.

There has been an attempt on the part of some computer companies andmakers of automatic analysis equipment to develop blood containeridentification systems which would act as an actuator to program theanalyzer or at least print out the patients name with the correspondingtest data. These systems however are oriented more toward avoidingclerical error between data and sample in the lab than toward insuringthat the sample gets to the laboratory properly identified. Most ofthese systems rely on the technicians bringing a prewritten pressuresensitive label to the bedside from the lab or nurses station, anddepends on the technician to verify the labels with the patientsidentification band. Thus, they remain vulnerable to mislabeling of thesample on collection.

One recent development such as that set forth in US. Pat. No. 3,523,522,to Whitehead, strives for a lock and key system which requires no mindtransfer" or memory in the collection system. The originalidentification is attached to the patient in the form of a code platemaster which allows electronic or mechanical printing of each label asit is required. This system requires expensive printers and electronicreaders and is directed strictly to blood collection tubes, thus havingno application as a general purpose sample label.

SUMMARY OF THE INVENTION This invention solves the previously-mentionedproblems by utilizing a whole new concept of in the area of patientidentification, namely the attachment of printed identification labelsto the hospital patients in such a way that they are readily availablefor use by the hospital staff for patient sample marking while providinga permanent identification for the patient during his hospital stay.

This invention relates to the dispensing of identification labels, froman attachment to a hospital patient, to preserve the integrity of sampleidentification; where samples are removable from the patient; where theattachment is preferably made to the wrist; where the dispenser is awrist band container of low profile; where the labels preferably arepressure-sensitive; and where the labels are pre-printed with thepatients identification information.

The attachment of an adequate supply of printed labels directly to thelimb of a patient offers a unique solution to the problem of samplemis-identification. The present practice is to bring labels to thepatient with this practice allowing room for the pick-up of wrong labelsbefore approaching the patient. It also allows the technician in apost-labeling procedure to select the wrong labels from a group oflabels. When labels are made at the nurses station prior to use, thewrong printer plate can be picked from the rack. In addition, when thenurse or the physician is taking thesample, labels are not normallyreadily available and tubes of blood left unlabeled at the nursesstation are often mixed up. Furthermore, all labeling systems now usinglabels rely on the hospital personnel to check the patientsidentificiation band for verification.

The use of a patient-attached supply of labels eliminates virtually allpotential sources and conditions of patient sample mix-ups. Pre-printedlabels save critical technician time and simplify the techniciansprocedure at a time when she is under the strain of patient contact. Inaddition, it forces attention to the identification band and verifiesthat the technician actually made patient contact. As a matter of fact,an additional label attached to the request form, after the samples havebeen drawn, would be verification that the samples were in fact taken.

In summary, the identification system of thisinvention includes anidentification assembly of the type having an elongated flexible bandwith fastening means for irreversibly locking the band to the limb of apatient wherein the improvement comprises the addition thereto of meansfor receiving a plurality of identification labels, with this receivingmeans including means for holding the labels so that no label can beadded without resultant indication thereof. This receiving means is alow profile, moisture-proof identification label dispenser (including acontainer and cover having an integral complementarily-mating closuremeans for detachably interlocking same) made of soft, flexiblenon-alergenic transparent plastic material of sufiicient optical qualityto allow easy reading of the labels therethrough. All but one of thelabels are removably held by the holding means and removal of the labelsrequires a pulling force which results in tearing of the label in thevicinity of the holding means, with the sensing of the pulling forceinsuring that no tampering has occurred. The identification labelspreferably are part of a label assembly further including a labelholding portion, and preferably the label rear surface is coated with apressure-sensitive adhesive.

The identification system of this invention also includes a method ofcorrelating the identity between a patient and specimens taken from thepatient wherein the steps comprise: attaching a label dispensing meansto the limbs of a patient; drawing a specimen from the patient into aspecimen container; removing a label from the label dispenser; andattaching the label to the container.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a top plan view, partiallybroken away, of the identification system of this invention in apartially assembled, unattached condition.

FIG. 2 is a sectional view showing the identification system when it hasbeen attached to and encompasses the limb of a patient and its cover hasbeen opened to permit removal of an identification label.

FIG. 3, which is an enlargement of the circled area of FIG. 2, shows therelationship of the various parts of the identification system.

FIG. 4 is a modification of the enlargement of FIG. 3.

DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring now to the drawingsin detail, FIGS. 1-3 show the identification system of this invention inthe form of identification assembly 10 and a method for using same.Identification assembly 10 is basically comprised of a flexible band 12having incorporated therein an identification label dispenser 14 adaptedfor receiving a plurality of identification label assemblies 16. Whileband 12 and dispenser 14, are made of a nonallergenic, flexiblematerial, preferably polyethylene plastic, they are also readily made ofother plastic materials such as polypropylene or polyvinylchloride.

Elongated, flexible band 12 includes a strap 18 and fastening means 20,with strap 18 being perforated to define a plurality of equally spacedopenings 22 along the length of the strap. Strap 18, which has its oneend portion 24 attached to one end of label dispenser 14, has its otherend portion 26 free to be attached to fastening means 20. Flexible bandsof the general type described herein are well known in the prior art,with examples thereof being set forth for instance in US. Pats.

In practice, for the installation of assembly on the limb of a patient,it is merely necessary to encompass (see FIG. 2) for example the wristand tosize assembly 10 to the wrist in the most comfortable manner byengaging strap 18, through the intermediary of one of the openings 22therein, upon flanged pin 34 of tab portion 28. Thereupon, upper tabportion 30 is folded along edge 32 and superimposed over the engagedportion of strap 18, with aperture 36 also being engaged by pin 34. Whenthis has been accomplished, the projecting portion 26 of the strap (notshown in FIGS. 2 and 3) is preferably cut with scissors. Both openings22 and aperture 30 are smaller in diameter than the maximum diameter offlanged pin 34 and once they are pressfitted over pin 34 they areirreversibly attached thereto (as best seen in FIG. 3). Thisirreversible attachment prohibits the interchange of assemblies 10between different patients. Removal of assembly 10 from the patientslimb requires the cutting of strap 18.

Each identification label assembly 16 (preferably of paper) is comprisedat least of identification label 38 and holding portion 40, with portion40 having a central aperture 44 and identification label 38 bearing atleast the name of the patient on the front surface thereof. The rearsurfaces of label 38 and portion 40 are coated with an adhesive means 46which may either be of the dry type (460), which is moisture-activated,or preferably of the pressure sensitive type (46b) which howeverrequires a backing or slip 48 (such as paper) that overlies adhesivemeans 46. Thus, label assembly 16a (FIG. 3) is a two-layer assembly,(e.g., label 38 and portion 40 covered on their rear surface by adhesivemeans 460), while label assembly 16b (FIG. 3) is a three-layer assembly(e.g., label 38 with portion 40 and backing 48, having adhesive means461) interposed therebetween).

As best seen in FIGS. I and 3, identification label 38 and holdingportion 40 abut at a common boundary 50 which, in the case of two-layerlabel assembly 16a, is preferably a perforation and in the case ofthree-layer label assembly is either also a perforation or preferably, aslit. If desired, backing 48 could also be perforated in the generalarea belowboundary 50.

As previously noted, interposed between strap inner end 24 and fasteningmeans is identification label dispenser 14 which is basically comprisedof label container 52 and cover 54, with cover 54 preferably beingconnected to container 52 by flexible connector por' tion 56. Whileconnector portion 56 is not required its use does allow the unitaryinjection molding of band I2, container 52 and cover 54 as one piece,and due to the immediate availability of cover 54, permits readyassembly of container 52 and cover 54.

Label container 52 is comprised of curved or arcuate bottom portion 58,similar end portions 60, 62 and sim-.

ilar curved or arcuate side portions 64, 66, with bottom portion 58preferably blending in with strap end portion 24 on one end and lowertab portion 28 on the other end. The upper surfaces of portions 60, 62,and

shape, has a pull tab portion 74 extending outwardly from one endthereof and a flanged pin 78 extending downwardly from cover innersurface 76 near the other end thereof. Since the minimum diameter ofcolumn internal bore 72 is smaller than the maximum diameter of flangedpin 78, once pin 78 is press-fitted into bore 72 they are irreversiblysecured together, i.e., cover 54 is fixedly attached near one end tocontainer 52 (as best seen in FIG. 3). Thus, another purpose of column70, together with pin 78, is to act as a securing means 79 forirreversibly securing one end of cover 54 to container 52.

In order to make labeldispenser 14 water tight, but yet allow theprogressive opening (and subsequent closing) of cover 54 with referenceto label container 52, cover 54 and container 52 are provided withintegral complementarily-mating closure means 80. Closure means 80preferably takes the form of a profiled, peripheral raised track 82,extending downwardly from cover inner surface 76, that detachablyinterlocks with a generally matching groove 84 in container peripheralrim 67.

Band 12 and dispenser 14, which are preferably injection molded as aunitary piece, are made of a transparent plastic of sufficient opticalquality as to allow easy reading of identification label 38 throughdispenser cover 54.

For maximum efficiency, label assemblies 16 preferably are printed, cut,hole punched, oriented and stacked by a stencil-type duplicatingmachine, with the label stencil preferably being generated as part ofthe hospital admittance form. In this manner, a plurality of labelassemblies 16, for example 20 to 25 assemblies, may be rapidly assembledinto dispenser compartment 68.

While one of the primary functions of the identification system of thisinvention is to provide multiple dispensable label assemblies, anotherprimary function is to provide for the attachment of one label as apermanent identification means in the event that the dispensable labelsare exhausted. This function preferably is accomplished by initiallyadhesively attaching a single label 38 on the inner surface of containerbottom portion 58 as shown in FIG. 3.v

Once the permanent label and the dispensable label assemblies are placedinto compartment 68, cover 54 is irreversibly secured to container 52 bypress-fitting flanged pin 78 into column bore 72. Compartment 68 is thenfully closed by pressing profiled track 82 of cover 54 into profiledgroove 84 of rim 67, with the flexibility of the plastic materialpermitting ready entry of track 82 into groove 84. Thereafter,identification assembly 10 is complete and it is then attached to thelimb of the patient in the manner already described. It should be notedthat if desired, assembly 10 can alternately be attached to the patientschart or two identical assemblies may be prepared at the same time, withone being attached to the patient and the other to his chart.

It should further be noted that it is considered to be within the scopeof this invention to combine label fastening means 20, column 70 (actingas a holding means for the label assemblies), and cover securing means79 (column 70 and pin 78) into one unitary, irreversible fastening means86 for simultaneously performing these stated functions.

This embodiment is shown in FIG. 4 as container 14a and is substantiallysimilar to container 14 previously described with reference to FIGS.l-3, with like members having like numerals. Fastening means 86, whichis a gripper type snap fastener of conventional design, is comprised ofstud portion 88 and cap portion 90. Cap portion 90is designed to bepressfitted or snapped over one end of portion 88 and thereafter isirreversibly attached thereto. As shown in FIG. 4, one end of studportion 88, extends into compartment 68a through aperture 92 in labelcontainer 520, while one end of cap portion 90 extends into compartment680 through band aperture 22 and aperture 94 in cover 54a.

PK]. 4 further illustrates a further integral, complementarily-matingclosure means 80a, in the form of a profiled peripheral raised track 96,on container peripheral rim 670, that detachably interlocks with agenerally matching groove 100 in downwardly extending peripheral coverlip 98.

It is also considered to be within the scope of this invention toutilize gripper-type snap fasteners (similar to fastening means 86) inplace of locking means and- /or cover securing means 79 shown in FIGS.1-3. Furthermore, the gripper-type snap fastener parts, i.e., studportion 88 and cap portion 90, may be added to assembly 10 at the timeassembly 10 is made up and attached to the patients wrist, or they maybe preassembled (e.g., portions 88 to lower tab portion 28 and/orcompartment 68; and portions 90 to upper tab portion 30 and/or cover54).

Since the method of use of assembly 10 is substantially identicalregardless of the use of either container 14 or container 140, thefollowing description, while specifically referring to container 14, isalso applicable to container 14a. For example, if a technician isrequested to obtain a blood sample from patient the technician, onapproaching patient "A," first of all visually checks hisirreversibly-attached identification assembly 10 to confirm that thispatient is patient Then, the technician extracts a specimen, such as asample of blood, from patient A" into a specimen container, such as aglass vacuum blood collection tube. Thereafter, upon grasping dispensercover pull tab portion 74 between thumb and forefinger, the technicianat least partially or progressively opens cover 54 by manually pullingthereon so as to at least disengage a portion of peripheral raised track82 from peripheral groove 84 in container rim 67. Thereupon, thetechnician grasps the top of label assembly 16 and removes it fromcompartment 68 by the application of a pulling force which, in the caseof 2 layer label assembly 16a, results in the tearing of label 38 fromholding portion 40 at perforation 50, with portion 40 remaining incompartment 68. Then, label adhesive means 46a is moistened and label 38is attached to the specimen container. In the case of preferred 3 layerassembly 16b, if

backing or slip 48 is not perforated, tearing occurs in the narrow areaof holding portion 40 between aperture 44 and the rear edge of assembly16b. Upon the removal of label assembly 16!), label 38 is readily peeledfrom backing 48 (after bending assembly 16b at slit 50) and, since ithas pressure sensitive adhesive backing 46b, it is merely pressed ontothe specimen container. (lf assembly 16b has a perforated backing 48,tearing will separate label 38 from holding portion 40.) Cover 54 isclosed by pressing peripheral track 82 back into groove 67, withreclosure of cover 54 taking place either immediately after the removalof the label or after the application of the label to the specimencontainer.

The identification system of this invention guards against tampering intwo ways, namely (1) it utilizes column as a label assembly holdingmeans and the combination of column 70 and pin 72 as an irreversiblesecuring means 79 so that the label assemblies are not only held, butthat no further or other label assemblies can be added to the containerwithout visual indication thereof, and (2) a pulling force (whichresults in tearing of the label assembly in the vicinity of the labelholding means) is required to effect label assembly removal, with thesensing of this pulling force insuring that no tampering has occurred.Thus, even if, for example, a label assembly 16b (with an unperforatedbacking 48) is removed from a first identification system and insertedinto a second system (by pushing the torn area of holding portion 40around column 70), this addition will readily be detected by thetechnician upon the subsequent removal of this added label assemblysince this removal will not require any appreciable force and thus willindicate tampering. Since label assembly 16a, and label assembly 16bwith a perforated backing, have holding portion 40 remaining incompartment 68 after the removal of label 38, these labels cannot bereinserted without visual and physical indications thereof.

With the identification system of this invention there remain two modesof system failure, namely: the extraction of a sample with no labelingof the sample and extracting a sample from the wrong patient, but withthe wrong patients own name attached thereto. Neither of these modes offailure represents a serious threat to the patient other than loss ofthe sample and loss of time. The other systems previously discussedleave room for mislabeling of the samples which is most serious sincethey can go through the system undetected and give false data.

The system of this invention in effect is a lock and key system as itdefinitely avoids misidentification. In addition, it reduces technicianmanipulation and label access is more rapid. When label making is doneon hospital admittance there is less patient stress. Furthermore, theidentification labels are applicable to any form of sample (or evenpersonal effects or valuables) and are always available for emergencyuse. Full patient information may be recorded on the labels. If desired,the use of multiple labels on a specimen container allows later transferof these labels to further sample containers for example one label canbe added to the specimen requisition form as verification that thesample was actually taken. Furthermore, due to its general low-profile,moisture-proof and tamperproof form the identification system concept ofthis invention is useful and complementary at any hospital size.

While this invention has been described in connection with possibleforms or embodiments thereof, it is to be understood that changes ormodifications may be from one of said label assemblies within saiddispensing means, and attaching said label to said container, whereinthe improvement comprises the step or irreversibly securing a labelholding portion of each of said label assemblies within said dispensingmeans with each label holding portion removably attached to anidentification label to insure that no tampering, in the form of addinga foreign label to said dispensing means, has occurred.

1. An improved method for correlating the identity between a patient andspecimens taken from said patient, including the steps of permanentlysecuring to a limb of a patient dispensing means having label assemblieswhich include a label holding portion and an identification labelremovably attached to said label holding portion, drawing a specimenfrom said patient into a specimen container, detaching an identificationlabel from one of said label assemblies within said dispensing means,and attaching said label to said container, wherein the improvementcomprises the step or irreversibly securing a label holding portion ofeach of said label assemblies within said dispensing means with eachlabel holding portion removably attached to an identification label toinsure that no tampering, in the form of adding a foreign label to saiddispensing means, has occurred.